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The Bionx Impact™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. The Bionx Impact™ Suture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, osteoporotic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3) Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6) Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.

Impact™ Suture Anchor is a smooth, cylindrical/conical shape, bioabsorbable, pushin suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Colour of green suture is D&C Green No 6, white suture represents original colour of polyester suture. Diameter of the anchor is 3.5mm and length 10.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a drill bit. The Impact™ Suture Anchor is made of poly-L/D-lactide copolymer.

The Bionx Duet™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Duet™ Suture Anchor is threaded, bioabsorbable suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Diameter of the anchor is 6.0mm and length 16.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a punch. The Duet™ Suture Anchor is made of poly-L/D-lactide copolymer.

1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. 1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the I ractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment and where pation of operation vecause the effect of the implant upon the healing of growth plate has not been tested clinically.

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074) - Lengths of implants are 16, 18, 20 and 25 mm. - - Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) 1 - Design of the implant of 1.5mm Bone Fixation Kit is identical with SmartNail -(K993074). - Shelf life is same with SmartNail™ - - Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus. The SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

The SmartScrew™ is composed of poly-L,D-lactide copolymer. It is supplied fully threaded with diameters 2.0mm - 4.5mm and lengths 10 - 70mm.

Properly used, in the presence of adequate immobilization, absorbable SmartNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. The SmartNail™ includes an arthroscopic applicator set. The arthroscopic applicator set consists of Handle, Tip, Piston, House, Wrench, Drill bit and K-wires. The SmartNail™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of SmartNail™ upon the healing of growth plate has not been tested clinically.

The SmartNail™ is provided with a diameter of 1.5 mm and lengths of 16, 20 and 25 mm. 5 barbs, placed at intervals of 1.5 mm on two sides of the SmartNail™, prevent the implanted SmartNail™ from slipping out. The SmartNail™ is made of polylactide homopolymer and polylactide copolymer materials with strength retention time 20-50 weeks.

The SmartScrew ACL™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions. The SmartScrew ACL™ is not intended for use in and is contraindicated for 1) cruciate ligament reconstructions, which would not be appropriate for fixation with metallic screws and 2) situations, where intra-articular replacement is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed (e.g., alcoholism).

The SmartScrew ACL™ a fully threaded, cannulated interference screw with slightly tapered head and tip. SmartScrew ACL™ is provided with three different diameter, 7.0, 8.0 and 9.0mm and with three lengths, 20, 25 and 30mm and it is made of poly-L/D-lactide copolymer.

The Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

The device description of the Meniscus Arrow™ is as follows. - Composed of poly-L/D-polylactide copolymer - Length 10, 13 and 16mm - Diameter 1.1mm The dimensions and shape are completely identical with the Biofix® Biodegradable Meniscus Arrow System (K955768).